Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
The mission of the Engineering Validation Department is to provide documented evidence that the Performance Qualifications (PQ) of manufacturing equipment and systems involved in commercial drug products produced at the Allston Landing Facility perform in a qualified and reproducible manner and comply with the diverse regulatory requirements necessary for product release on a global scale. Moreover, Engineering Validation's scope of work also includes CIP, SIP and Autoclave cycle development as well as Performance Qualification of the same. The deliverables of the Engineering Validation Department include approved Final Reports for Qualification studies. These reports, and the protocols which drive them, are made available to the world-wide regulatory agencies via inclusion within regulatory filings, and during audits and inspections of the Allston Landing Facility.
The Principal Validation Engineer: Projects (PVE) reports directly to the Director of Engineering. The position will be responsible for performing validation in a GMP biotech manufacturing facility managing large size validation projects utilizing internal and external resources, and supervising technicians/engineers as well as acting as a back up to Validation Manager as necessary.
The PVE will be responsible for development of Validation Plans for large size validation projects, VMP maintenance and periodic reporting. Additional responsibilities include Qualification and Validation of equipment, facilities, utilities, cleaning, sterilization, and manufacturing processes presentation to of validation documents and strategies to Senior Management and regulatory agencies. The PVE may be responsible for Managing a team of subcontractors to support Engineering Projects and for Project Management of these subcontractor teams.
The PVE will also be responsible for generation of complex protocols using risk based approach meeting current regulatory requirements and industry practices, review and approval of validation protocols and reports, as well as leading Design Qualification. This position requires conducting duties during 2nd or 3rd shifts when necessary (typically 10-20% of the time). Some travelling may be involved.
· Engineering or science Bachelor's degree with a minimum of 12 years of experience in the industry (9 years validation) or a Master's degree with a minimum of 10 years of experience in the industry (8 years validation)
· Working knowledge of GMPs, ICH Q8, Q9, Q10 and other international regulatory requirements
· Strong leadership skills
· Project and staff management
· Innovative and capable of developing alternative solutions to issues at hand
· Validation using risk based approach (FMEA, PHA, etc)
· Ability to read/interpret engineering drawings and design documents
· Development of project execution plan and management of large size projects
· Knowledge of Validation Lifecycle Approach (e.g. ASTM E2500)
· Conducting statistical analysis of validation test results
· Investigation/ troubleshooting of validation problems
· Leading design qualification activities
· Contributing to regulatory documents development
· Excellent technical writing, verbal communication, and presentation skills
· Must be people oriented and a team player
· Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio
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